Agfa-Gevaert NV
Agfa es un líder mundial en tecnología de imágenes y soluciones de TI para atención médica, artes gráficas y...
Agfa es líder mundial en tecnología de imágenes y soluciones de TI para atención médica, artes gráficas y materiales especiales. La sede de Mortsel fabrica detectores digitales de rayos X, sistemas de mamografía, escáneres CT, software informático de radiología (XERO Viewer) y medios de impresión de inyección de tinta. Los productos se distribuyen a hospitales, centros de diagnóstico por imágenes e imprentas comerciales en más de 100 países. La división de Productos Especiales de Agfa produce películas especiales y papeles de seguridad para impresión gubernamental e industrial.
- Type
- brand seeking distribution
- Location
- Mortsel, Belgium
- Founded
- 1867
- Website
- agfa.com
- Categories
- Suministros médicos y sanitarios, Embalaje y suministros de impresión
- Markets
- Estados Unidos, Alemania, Japón, Reino Unido, Francia
Verified facts
- corporate-mail-on-domain (green), checked 2026-08-03 Mail server of the company domain
- debarment-clear (green), checked 2026-08-03 OpenSanctions
- registered-manufacturer (green), checked 2026-08-21 ALIMS (Medicines and Medical Devices Agency of Serbia), register of medical-device manufacturers
- sanctions-clear (green), checked 2026-08-03 OpenSanctions
- domain-registered (green), checked 2026-08-03 Domain registry record
- lei-active (green), checked 2026-08-23 GLEIF global LEI register (golden copy)
- aeo-certified (green), checked 2026-08-30 EU AEO register (European Commission)
Claimed certifications
- ISO 9001, Quality Management IAF CertSearch
- ISO 13485, Medical Devices Quality IAF CertSearch
- AEO, Authorised Economic Operator EU AEO database
Import rules for these goods
- Medical devices sold in the EU must carry CE marking under the Medical Device Regulation (EU) 2017/745, with a conformity assessment matched to the device risk class. European Commission (MDR)
- For the US market, the maker must have an FDA device establishment registration and product listing; most instruments also need 510(k) premarket clearance. US FDA (devices)
- If the goods are paper, board or printed products, EU imports fall under the Deforestation Regulation (EUDR) due-diligence regime; packaging machinery itself does not. European Commission (EUDR)
- No public registry exists for certificates of this kind in this sector: conformity is declared by the manufacturer. European Commission: CE marking, manufacturer's conformity assessment